EMAeHealth, a digital tool for the self-management of women’s health needs during pregnancy, childbirth and the puerperium: protocol for a hybrid effectiveness-implementation study

INTRODUCTION: EHealth can help health service users take a more active role in decision-making and help health professionals guide the patient in this process. A digital tool has been designed to support maternal education (ME), and it is organised into four areas: (1) information, (2) communication, (3) health self-management and (4) clinical data. The main objective of the study is to evaluate the effectiveness of the EMAeHealth digital tool, and assess its usability and acceptability under routine conditions. METHODS AND ANALYSIS: Hybrid implementation-effectiveness design: (1) A cluster randomised, prospective, longitudinal, multicentre clinical trial to evaluate the effectiveness of EMAeHealth in (A) improving health-related quality of life (primary outcome), (B) improving self-efficacy for labour and childbirth and self-efficacy in breast feeding and (C) reducing the number of visits to the obstetric emergency services and health centre in situations of ‘non-pathological pregnancy’, ‘false labour pains’ and ‘non-pathological puerperium’. The EMAeHealth intervention plus usual care will be compared with receiving only usual care, which includes traditional ME. N=1080 participants, 540 for each study arm. Two measurements will be made throughout the pregnancy and three in the first 16 weeks post partum. (2) A mixed-method study to evaluate the usability and acceptability of the tool, barriers and facilitators for its use, and implementation in our health system: focus groups (women, professionals and agents involved) and a quantitative analysis of implementation indicators. Analysis: It will be carried out by intention to treat, using mixed models taking into account the hierarchical structure of the data and per protocol to evaluate the effectiveness of the express use of the digital tool. ETHICS AND DISSEMINATION: Clinical Research Ethics Committee of Euskadi, Spain, (Ref: PI2020044) approved this study. The results will be actively disseminated through manuscript publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT04937049.